Drug Interaction:
Alcohol, smoking, hepatotoxic drugs, Osetrogens, propranol,
Rifampicin, Other anti-depressants
May increase risk of delirium when used with antimuscarinics
Increased risk of extrpyramidal symptoms and neuroleptic malignant syndrome
when used with aripiprazole.
Sodium levels may be reduced by carbamazepines
Concurrent use with dihydroergotamine or linezolid may lead to serotinin syndrome.
May increase serum levels of lemotrigine and risk of toxicity.
May increase serum levels of olazipine, pimozide, risperidone , methadone, clonazapine
and amiodarone
Plasma levels may be increased by cimetidine and ritonavir.
May increase the anicoagulant activity of warfarin, and acenocumarol.
Concurrent admin with MAOI can result in serious serotonin syndrome
Indication:
Major depressive disorders
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
Agomelatine tablets 25mg 10-09-2012
For the treatment of major depression in adult patients aged 18-65
years only with normal liver functions
Adverse Reaction:
Headache, dizziness, somloence, insomnia, back pain, fatigue, anxety
Suicidal ideation, agitation, manialhypomania, urticaria, rash, hepatitis
Raised ALT or AST
Contra-Indications:
Hepatic impairment or transaminase > 3x ULN
Concomittant admin of fluvoxamine, ciprofloxacin,
and other potent CYP1 A2 inhibitors
Galactose intoleance, Laplactase deficiency,
glucoselgalactose malabsorption
Elderly over 65 if suffering from dementia or over 75 years
Pregnancy, Lactation
Special Precautions-
Moderate to severe impairment. Perform LFTs at initiation and when increasing dose
at weeks 3,6,12, and 24 and periodically thereafter.
Repeat within 48 hours if ALT or AST raised , discontinue if > 3 xULN
Advise patients to report symptoms of liver injury , discontinue immediately
if occur.
Obesity, overweight, non-alcoholic fatty liver disease, diabetes
History of bipolar disorder , mania or hypomania,
discontinue if maniac symptoms devlop.
Monitor for sucidal ideation . E.C.T
Dosages/ Overdosage Etc:
Indication-
Major depressive disorders
Dosage-
25mg once daily at bed time
If no improvement after 2 weeks, increase to 50mg once daily.
Below 18 years not recommended
Manufacturer Details